Legal problems are often multi-faceted. Turned one way, the problem looks like one issue. Turn it around, and a different issue glimmers in your eye.
For example, in Saulsby v. Amphastar Pharm., Inc., __ S.E.2d ___, 2025 N.C. App. LEXIS 420, 2025 WL 1812450 (N.C. App. July 2, 2025), the North Carolina Court of Appeals affirmed summary judgment on contributory negligence grounds, but it just as easily could have relied on a warnings causation theory.
Saulsby is a product liability case involving, sadly and unfortunately, a death. Nothing in the opinion discusses medical causation, and we have no basis to understand how this would be scientifically plausible, but the complaint alleged the decedent died after self-administering a single dose of an over-the-counter (OTC) asthma inhaler.
The OTC inhaler been purchased by the decedent’s long-term boyfriend to alleviate her shortness of breath. The product’s intended use was for “temporary relief of mild symptoms of intermittent asthma,” and it carried express warnings: “Do not use unless a doctor said you have asthma” and “Ask a doctor before use if you have . . . heart disease [or] high blood pressure.”
Contrary to those warnings, the decedent had not been diagnosed with asthma, and she did have multiple underlying health conditions including heart disease and high blood pressure. In addition, no doctor was consulted. The boyfriend allegedly asked a pharmacist whether the product was “good for breathing” but the question was posed without any context about the decedent’s health history or immediate medical need.
Moreover, the product’s warnings were not read by the boyfriend at the time of purchase, and there was no evidence the decedent read them prior to use either.
North Carolina’s product liability landscape is one we generally like. Here, the decedent’s estate sued the manufacturer for negligence (N.C. does not recognize strict liability) and breach of the implied warranty of merchantability.
After the trial court granted summary judgment, finding the decedent’s contributory negligence barred recovery under N.C. Gen. Stat. § 99B-4, the North Carolina Court of Appeals agreed that the decedent’s own negligence was clear and affirmed.
N.C. Gen. Stat. § 99B-4—a most useful statute—provides that a manufacturer or seller is not liable in a product liability action if:
(1) The use of the product giving rise to the product liability action was contrary to any express and adequate instructions or warnings delivered with, appearing on, or attached to the product or on its original container or wrapping, if the user knew or with the exercise of reasonable and diligent care should have known of such instructions or warnings; or
(2) The user knew of or discovered a defect or dangerous condition of the product that was inconsistent with the safe use of the product, and then unreasonably and voluntarily exposed himself or herself to the danger, and was injured by or caused injury with that product; or
(3) The claimant failed to exercise reasonable care under the circumstances in the use of the product, and such failure was a proximate cause of the occurrence that caused the injury or damage complained of.
The court rejected the plaintiff’s argument that this statute requires a determination of whether the decedent exercised reasonable care under the circumstances and whether the warning was adequate, because the statute pretty clearly uses the disjunctive or between its prongs.
It also distinguished prior pharmacy cases that had chipped away at the statute (based on allegations the plaintiff was given the wrong product, or there were extenuating circumstances, or there were individualized warnings from a pharmacist).
The evidence established that both the decedent and her boyfriend either knew or should have known of the product’s express warnings, and in not reading them failed to exercise the care an ordinarily prudent person would have under similar circumstances, barring both the negligence claim and the implied warranty claim.
This conclusion tracks. But even without the North Carolina statute, should a claim based on facts like these pass muster? If the claim is for failure to warn, absolutely not.
The idea behind a failure to warn claim is that if only the manufacturer had given a different, stronger, more adequate warning, then the harm never would have occurred—the prescription product never would have been prescribed or, with an OTC product, the consumer would have not taken the product or they would have followed the labeling.
But on the facts of Saulsby, the flaw in that theory of liability is that it did not matter what the warnings said, because the decision-makers never read them. In other words, the plaintiff cannot prove that the allegedly defective warning caused the harm, because the allegedly defective warning had no effect whatsoever. (We have a comprehensive post on failure to read warnings and causation.)
Facts like those in Saulsby are one of the reasons we think the “heeding presumption” is nonsense. Plenty of consumers take OTC medicines without much thought, after a quick trip to the store and maybe a cursory scan of the products on the shelves or an out-of-context question posed to someone behind the pharmacy counter. These are the type of events that are entirely commonplace. Maybe these are not the actions of an ordinarily prudent person when it comes to medications, but they are not rare. States that use the heeding presumption tip the scales in plaintiffs’ favor by presuming (absent contrary evidence) that everyone always will read and heed a product label. But we know people don’t, so the law should not ignore real life and presume that they will.
Anyway, this court came out the right way. We just would like to think that failure to read facts like these would end in summary judgment even in states without North Carolina’s sensible contributory negligence statute.